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Last Updated: December 22, 2024

OXYTOCIN 20 USP UNITS IN DEXTROSE 5% Drug Patent Profile


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Which patents cover Oxytocin 20 Usp Units In Dextrose 5%, and what generic alternatives are available?

Oxytocin 20 Usp Units In Dextrose 5% is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in OXYTOCIN 20 USP UNITS IN DEXTROSE 5% is oxytocin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oxytocin 20 Usp Units In Dextrose 5%

A generic version of OXYTOCIN 20 USP UNITS IN DEXTROSE 5% was approved as oxytocin by HIKMA on January 10th, 2007.

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Summary for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%
Drug patent expirations by year for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%
Recent Clinical Trials for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital, Gentofte, CopenhagenN/A
University of Colorado, DenverPhase 2
Karolinska InstitutetPhase 2

See all OXYTOCIN 20 USP UNITS IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott OXYTOCIN 20 USP UNITS IN DEXTROSE 5% oxytocin INJECTABLE;INJECTION 019185-002 Mar 29, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

OXYTOCIN 20 USP UNITS IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxytocin 20 USP Units in Dextrose 5%

Market Overview

The global oxytocin market, which includes formulations like Oxytocin 20 USP Units in Dextrose 5%, is experiencing significant growth driven by several key factors.

Rising Incidence of Pregnancy Complications

The increasing incidence of pregnancy complications and postpartum hemorrhage is a major driver of the oxytocin market. According to the World Health Organization (WHO), maternal mortality rates remain high, with approximately 287,000 women dying during or after pregnancy and childbirth in 2020. This has led to a greater demand for oxytocin, which is used to induce labor and control postpartum bleeding[3].

Growing Childbirth Rates and Cesarean Deliveries

The global increase in childbirth rates and the rising number of cesarean deliveries are also contributing to the market growth. Cesarean section deliveries now account for over one in five (21%) of all childbirths, and this trend is expected to continue, with projections indicating that nearly a third (29%) of all births will be via cesarean section by 2030[3].

Market Segmentation

Indications

The oxytocin market is segmented into antepartum and postpartum indications. The postpartum segment holds the largest market share due to the increasing need to manage postpartum hemorrhage, a condition that can arise from uterine atony, placental issues, or trauma during delivery. Oxytocin is a critical uterotonic agent in this context, helping the uterus contract and reduce bleeding[3].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, drug stores, and online pharmacies. Hospital pharmacies are expected to grow significantly due to the preference for hospital settings for treatment, where pharmacists ensure medication safety and quality control[3].

Regional Market Dynamics

North America

North America currently holds the largest market share, driven by substantial research investments by private entities and government agencies in the healthcare sector. The region is home to significant pharmaceutical corporations and research facilities, which contribute to the development and marketing of oxytocin products[3].

Asia-Pacific

The Asia-Pacific region is expected to grow at the fastest rate over the forecast period. This growth is attributed to increasing healthcare infrastructure, rising awareness of induced labor and breastfeeding, and a growing population requiring obstetric care[3].

Financial Trajectory

Market Growth Rate

The global oxytocin market is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2030. This growth is driven by the increasing demand for oxytocin in both antepartum and postpartum care, as well as advancements in medical guidelines and clinical practices[3].

Key Players and Strategic Initiatives

Major players in the oxytocin market, such as Pfizer Inc., EVER Pharma, and Fresenius Kabi AG, are engaged in new product development, mergers and acquisitions, and strategic alliances to expand their market presence. For example, in July 2023, Endo International plc and Premier, Inc. collaborated to address a shortage of Pitocin (oxytocin injection, USP)[3].

Pricing and Cost Considerations

Dosage Forms and Pricing

Oxytocin is available in various dosage forms, including intravenous solutions and intramuscular injections. The pricing varies based on the concentration and volume of the solution. For instance, Oxytocin 20 USP Units in 500 mL of 5% dextrose solution has specific pricing that reflects its clinical utility and production costs[1][2].

Storage and Stability

The stability and storage requirements of oxytocin solutions also impact their cost and availability. Oxytocin is stable in 0.9% sodium chloride or 5% dextrose solutions for 24 hours but is unstable in solutions containing preservatives. This necessitates careful handling and storage, which can influence the overall cost of the medication[2].

Clinical Use and Administration

Indications for Use

Oxytocin 20 USP Units in Dextrose 5% is used to induce or strengthen uterine contractions in pregnant women to aid in labor and delivery or to control postpartum bleeding. It is administered intravenously, with the initial dose typically ranging from 1 to 4 mU/min, which can be increased until a contraction pattern similar to normal labor is established[2][5].

Administration Guidelines

The administration of oxytocin requires careful monitoring of fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions. The solution must be clear and free of particulate matter before administration, and the bottle or bag must be turned upside down at least once to ensure homogeneity of the drip solution[2][5].

Future Outlook

Advancements in Medical Guidelines

Advancements in medical guidelines and clinical practices are expected to continue driving the use of oxytocin as a standard procedure in both vaginal and cesarean deliveries. This will enhance patient safety and outcomes, further solidifying the market position of oxytocin products[3].

Emerging Technologies and Products

New product developments, such as intranasal potentiated oxytocin (e.g., TNX-1900 by Tonix Pharmaceuticals), are expanding the potential applications of oxytocin beyond traditional obstetric uses. These innovations are likely to contribute to the continued growth of the oxytocin market[3].

Key Takeaways

  • The global oxytocin market is growing at a CAGR of 6.1% from 2024 to 2030.
  • Rising pregnancy complications, increasing childbirth rates, and growing cesarean deliveries are key drivers.
  • The postpartum segment holds the largest market share due to the need to manage postpartum hemorrhage.
  • North America currently leads the market, but the Asia-Pacific region is expected to grow rapidly.
  • Major players are engaging in new product development and strategic alliances to expand market presence.

FAQs

Q: What are the primary uses of oxytocin in obstetrics? A: Oxytocin is used to induce or strengthen uterine contractions to aid in labor and delivery or to control postpartum bleeding.

Q: How is oxytocin typically administered? A: Oxytocin is administered intravenously, often in a solution of 5% dextrose or 0.9% sodium chloride, with careful monitoring of uterine contractions and fetal heart rate.

Q: What are the stability and storage requirements for oxytocin solutions? A: Oxytocin solutions are stable in 0.9% sodium chloride or 5% dextrose for 24 hours but are unstable in solutions containing preservatives. They should be stored between 20°C and 25°C and protected from freezing[2].

Q: Which region is expected to grow the fastest in the oxytocin market? A: The Asia-Pacific region is expected to grow at the fastest rate over the forecast period due to increasing healthcare infrastructure and a growing population requiring obstetric care[3].

Q: What are some of the key players in the oxytocin market? A: Major players include Pfizer Inc., EVER Pharma, Fresenius Kabi AG, and others, which are involved in new product development, mergers and acquisitions, and strategic alliances[3].

Sources

  1. DrugBank Online: Oxytocin: Uses, Interactions, Mechanism of Action.
  2. Pfizer Canada Inc.: PRESCRIBING INFORMATION Oxytocin Injection USP.
  3. Grand View Research: Oxytocin Market Size, Share & Growth Analysis Report, 2030.
  4. FDA: Pharmedium Services, LLC, Sugar Land, TX., 483 issued 12/22/2017.
  5. FDA: Oxytocin Injection, USP - accessdata.fda.gov.

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